Director of Cell Biomanufacturing

hace 4 semanas

Playas de Tijuana, México Cellular Performance Institute A tiempo completo

**World renowned Cellular Performance Institute looking for a Director of Cell Biomanufacturing**

The Cellular Performance Institute, located in Playas de Tijuana, is looking for a Director of Cell Biomanufacturing responsible for overseeing the development, scale-up, and production of cell-based products. This position plays a critical role in ensuring that manufacturing processes meet regulatory requirements and industry standards while optimizing efficiency and maintaining the highest quality standards.

We are considered by many to be the world's premiere facility for stem cell treatments and manufacturing. Our weekly stream of clientele include professional athletes from the UFC, NFL, MLB and more.

**Responsibilities**:

- Optimization of laboratory staff performance.
- Laboratory training programs.
- Laboratory materials management program
- Laboratory equipment, and instrument management program
- Evaluation, development, and implementation of new processes, methodologies,
- instrumentation or software to improve efficiency, reduce operating costs, and/or drive the department toward state of the art technology.
- Safety of the workforce through administration of safety policies and monitoring of safety incidents.
- Collaborate with the leadership team to develop and implement strategic goals and objectives that support

**Scientific and Technical Policies, Processes, and Procedures**:
**Direct laboratory management with oversight of**:

- All processes to ensure compliance with current Good Manufacturing Processes (cGMP) and acceptable levels of analytical performance are maintained
- Department documents, procedures and actions are compliant with all laws, regulations, standards, and policies.
- Standard Operating Procedures (SOPs) reflect the work performed, are revised in a timely manner when procedures change, and are organized in a manner to be highly effective for training and actual performance of work.
- Tissue/cell collections manager to support technical and quality processes and procedures and ensure recruitment, collection and transportation activities are compliant with applicable regulations and standards.
- Manage new projects and develop new processes/techniques to meet department objectives.

**Quality Program**:

- Serve as primary laboratory SME for any internal and external reviews, audits, and submissions.

**Direct lab management with oversight to ensure the following**:

- Current Good Manufacturing Practice (cGMP), Good Tissue Practice (cGTP), Good Documentation Practice (cGDP), Good Laboratory Practice (cGLP), and other applicable cGxP are employed and acceptable levels of analytical performance are maintained.
- Departmental policies, processes, and procedures are compliant with applicable laws, regulations, and standards SOP accurately reflect work being performed, are revised in a timely manner when procedures change, and are organized in a manner to be highly effective for training and actual performance of work.
- Direct lab management with oversight of Occurrence Process.
- Record maintenance and retention, including but not limited to staff training records, processing records, testing records, validation/qualification protocols, and equipment/instrument maintenance.
- Departmental validation/qualification protocols creation, approval, execution, completion, and implementation.
- Evaluation, development and implementation of new processes, methodologies, instrumentation or software.
- Direct lab management with development and review of budget(s), preparing monthly reconciliations and forecasts as requested, and financial models for long‐term planning.

**We Offer**:

- Competitive salary.
- Direct contract with the company.
- All benefits by Law.
- IMSS.
- INFONAVIT.
- FONACOT.
- Grocery vouchers.
- Uniforms.
- Free emotional support sessions.
- Medical Consultations.
- Free laboratory studies, radiology and imaging.

**Schedule**:

- Monday to Friday 9am-5pm

**Salary**:

- $52,500MXN gross monthly

**ABOUT US**

Pay: From $52,500.00 per month

Work Location: In person

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